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Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment

RecruitingPhase 2Ages 18 Years - 100 YearsFemaleHospital Mutua de Terrassa
NCT06404931 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a randomised study in which we compare the effectiveness of three different procedures in mending symptomatic anterior and apical prolapse in patients who are candidates to receive surgery. They will be randomly assigned in a ratio 1:1:1 to three different groups who will have assigned three different kinds of surgery. In the patients of the first group a classic vaginal hysterectomy with anterior colporrhaphy will be practised. Patients who belong to group two will undergo a vaginal hysterectomy followed by placement of an acellular dermal matrix from cadaveric donors (hADM) for anterior reinforcement and sacrospinous fixation with Anchorsure® device (Neomedic trade mark (TM) International, Spain). Finally, patients from group three will have vaginal hysterectomy followed by sacrospinous fixation with Anchorsure® alone . Patients will be followed-up at 4 weeks, 6 months, 12 mo

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📋 Eligibility rules (as published)
Inclusion Criteria: * Women with symptomatic POP with indication of vaginal surgery. * Women with hiatal ballooning or levator ani injury evaluated by 3D pelvic floor ultrasound. * Women ≥18 years old. * Women wishing to complete a 36-month follow-up. * Understand and accept the study procedures and sign the informed consent. Exclusion Criteria: * Women with previous pelvic floor or prolapse surgery * Women with POP grade IV * Women with chronic pelvic pain. * Not being able to understand the nature of the study and/or the procedures to be followed. * Not signing the informed consent
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What it tests

  • Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device
  • Vaginal hysterectomy plus anterior colporrhaphy
  • Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device
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Where

1 site
Hospital Mutua de Terrassa
Terrassa, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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